Vivek Ra­maswamy re­cruits Eli Lil­ly R&D vet Salz­mann as new CEO; Ax­o­vant drops col­lab­o­ra­tion

Vivek Ra­maswamy has re­cruit­ed Eli Lil­ly R&D vet Pe­te Salz­mann to take the helm at one of his new vants. Salz­mann is the new CEO at Im­muno­vant, which is work­ing on IMVT-1401, a mon­o­clon­al an­ti­body in de­vel­op­ment for the treat­ment of au­toim­mune dis­eases me­di­at­ed by path­o­gen­ic IgG an­ti­bod­ies. Salz­mann had been in charge of the de­vel­op­ment pro­gram for Olu­mi­ant (baric­i­tinib), which proved trou­ble­some for Eli Lil­ly as reg­u­la­tors raised se­ri­ous con­cerns about safe­ty.

A cou­ple of weeks af­ter up­dat­ing their plans for their new spin-off com­pa­ny, first an­nounced last year, UK-based Mallinck­rodt — the mak­er of the con­tro­ver­sial drug Ac­thar — an­nounced to­day that it has “reached an agree­ment with the US DoJ to re­solve the pre­vi­ous­ly dis­closed gov­ern­ment in­ves­ti­ga­tion of Quest­cor’s lega­cy sales and mar­ket­ing ac­tiv­i­ties, which is still sub­ject to the fi­nal­iza­tion of cer­tain terms.”

The com­pa­ny says that the gov­ern­ment is try­ing to re­cov­er mon­e­tary dam­ages — al­leged­ly made by the lega­cy Quest­cor char­i­ta­ble foun­da­tion be­tween 2010 and 2014 — for al­leged vi­o­la­tions of the False Claims Act and the An­ti-Kick­back Statute.

“Con­trary to the DOJ’s char­ac­ter­i­za­tions in the com­plaint, the al­le­ga­tions re­late to lega­cy Quest­cor con­duct as all the do­na­tions to the Chron­ic Dis­ease Fund (CDF) ref­er­enced in the com­plaint oc­curred pri­or to the ac­qui­si­tion of Quest­cor or were for grand­fa­thered pa­tients who had been ap­proved by CDF for co-pay as­sis­tance pri­or to the ac­qui­si­tion. Mallinck­rodt ac­quired Quest­cor in Au­gust 2014.”

The com­pa­ny ex­pects to pay $15.4 mil­lion in re­la­tion to lega­cy Quest­cor ac­tiv­i­ties.

Ax­o­vant is drop­ping its li­cense and col­lab­o­ra­tion agree­ment with Ben­itec Bio­phar­ma — which in­clud­ed AXO-AAV-OP­MD, treat­ment of ocu­lopha­ryn­geal mus­cu­lar dy­s­tro­phy (OP­MD), and dis­cov­ery stage re­search col­lab­o­ra­tion pro­grams — in its en­tire­ty.

In ad­di­tion, Ax­o­vant re­port­ed six-month fol­low-up da­ta for its gene ther­a­py, AXO-Lenti-PD — a treat­ment for Parkin­son’s dis­ease — from the first dose co­hort in the open-la­bel, dose-es­ca­la­tion por­tion of its on­go­ing SUN­RISE-PD Phase II tri­al. The com­pa­ny not­ed that there were “no se­ri­ous ad­verse events re­lat­ed to the prod­uct or pro­ce­dure” and that pa­tients were con­tin­u­ing to show im­prove­ment from base­line across mul­ti­ple mea­sure­ments. 

 

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Proven­tion Bio's J&J-li­censed Crohn's drug stum­bles in mid-stage study

One of the drug’s Oldwick, New Jersey-based Provention Bio joined forces with J&J on — has failed a mid-stage study.

The company was testing the experimental therapy, PRV-6527, which was originally developed by J&J and is designed to inhibit colony-stimulating factor 1 receptor (CSF-1R) signaling. It was being tested in a Phase IIa study, dubbed PRINCE, in 93 moderate-to-severe Crohn’sCrohn’s disease patients who were either naïve to biologic therapy (~70%) or who had previously failed at least one biologic drug (~30%).

Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experience. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.